Medical Device Complaint Analyst I - Regulatory Reports

Boston Scientific; Marlborough (MA); Hybrid; USD 51,000 - 97,000; Full time

Job summary

Boston Scientific in Marlborough, MA is seeking a Product Complaint Analyst I to join the Urology Complaint Management Center. In a fast-paced environment, you will analyze customer complaints for regulatory reportability and coordinate with internal teams and field personnel.

You will apply clinical knowledge, write regulatory reports, and ensure timely submissions. The role follows a hybrid work model requiring three days in the office each week, with relocation not offered.

Qualifications

• Bachelor’s degree or equivalent education.
• Excellent written and verbal communication skills are essential.
• 1+ years of experience in medical device complaint processing & reporting.
• Self-motivated, goal-driven, and results-oriented team player.
• Critical thinking and good time-management skills.
• College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred.

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability and impact on patient safety and operations.
• Apply clinical knowledge to evaluate complaints and gather data from clinical staff, field reps, internal staff, and labs.
• Establish regulatory reportability decisions using investigation and models.
• Develop and modify decision models to stay compliant with regulations as products evolve.
• Write Medical Device Reports and regulatory reports and submit timely to authorities.
• Code events accurately and review coding with engineering and labs.
• Communicate findings and corrective actions in writing to physicians and end users.

Skills

Excellent written and verbal comms

1+ years of medical device complaint m

Self-motivated and results-oriented

Critical thinking

Education

Bachelor’s degree or equivalent education

Biology/Health Sciences/Biotechnology/Engineering focus preferred

Job description

Boston Scientific in Marlborough, MA is seeking a Product Complaint Analyst I to join the Urology Complaint Management Center. In a fast-paced environment, you will analyze customer complaints for regulatory reportability and coordinate with internal teams and field personnel.

You will apply clinical knowledge, write regulatory reports, and ensure timely submissions. The role follows a hybrid work model requiring three days in the office each week, with relocation not offered.